Breakthrough Gene Therapy Clinical Trial in Colombia Aims to Cure Alzheimer's Disease And Could Reverse 20 Years of Age on Patients

Libella Gene Therapeutics will use clinically-proven gene therapy techniques that Dr. Bill Andrews —a pioneer in the field of using human telomerase gene therapy— developed at Sierra Sciences. This clinical trial will lead to the world’s most expensive treatment and first cure ever for Alzheimer's disease.

Traditional clinical trials in the U.S. can take years and millions — or even billions — of dollars. We believe we have the scientist, the technology, the physicians, and the lab partners that are necessary to get this trial done faster in Colombia.

— Jeff Mathis, Ph.D, President at Libella Gene Therapeutics, LLC

[ORLANDO, FL, January 5, 2018] - Libella Gene Therapeutics, LLC ("Libella") announces a clinical trial project in Colombia (South America) using gene therapy to treat and ultimately cure Alzheimer's disease. This project —designed and managed by bioaccess.™— could lead to Libella offering the world's most expensive treatment in excess of $5 million to cure Alzheimer's disease and reverse about 20 years of age on patients.

Every day 228 Americans die from Alzheimer's disease, and there is currently no known treatment or cure for the disease. Gene therapy offers the ability to permanently correct a disease at its most basic level, the genome, and could offer cures for many conditions that are considered incurable. Unlike traditional drugs, which tend to be taken for months or years at a time, gene therapy interventions are intended to be one-off treatments that tackle a disease at its source; repairing faulty DNA so the body can fix itself.

The human telomerase reverse transcriptase (hTERT) is an enzyme that expression plays a role in cellular aging. It is normally repressed in cells, resulting in progressive shortening of telomerase. Telomerase gene therapy in adult and old mice delays aging and increases longevity. The clinical trial —Study Involving new gene-therapy using Libella’s AAV Reverse (hTERT) Transcriptase enzyme (aka "Project Singularity")— will treat patients using gene therapy treatment to lengthen telomeres. Libella believes the lengthening telomeres is the key to treating and possibly curing Alzheimer's disease. Libella's' gene delivery system has been demonstrated as safe, with minimal adverse reactions in over 186 clinical trials.

Bill Andrews, Ph.D. has been featured in Popular Science, The Today Show and numerous documentaries on the topic of life extension including, most recently, the documentary The Immortalists in which he co-stars with Aubrey de Grey —one of the world's leading researchers on age-related diseases. Dr. Andrews is the principal discoverers of both the RNA and protein components of human telomerase. He is also a named inventor on over 50+ US-issued patents on telomerase and author of numerous scientific research studies published in peer-reviewed scientific journals.

On why they decided to conduct its project outside the United States, Libella's President, Dr. Jeff Mathis, said, "Traditional clinical trials in the U.S. can take years and millions—or even billions—of dollars. The research and techniques that have been proven to work are ready now. We believe we have the scientist, the technology, the physicians, and the lab partners that are necessary to get this trial done faster —and at a lower cost— in Colombia."

The clinical trial is prepping to begin in the first quarter of 2019 and will be conducted at a leading research center in Colombia —pending approval from its institutional review board (IRB) and Colombia's regulatory agency, INVIMA.

Patients participating in the trial will be enrolled in the US and will travel to Colombia to participate in the clinical trial. Patients will stay in Colombia for four days while the treatment is administered and hospitalized for observation. After the four days, patients will return to the US and will be follow-up per the study protocol. The protocol synopsis is available (in Spanish) here.

Colombia’s regulations (Resolution 8430 of 1993) are friendly to gene therapy clinical trials. The approval of a gene therapy trial at a research center in Colombia takes about 30-45 days from the date of IRB submission. After IRB approval, INVIMA will approve a gene therapy trial in about 90 days. This positions Colombia as the country with the fastest approval time in Latin America for gene therapy and biotechnology clinical trials.

PROCOLOMBIA —the country's tourism, foreign investment, and export promoting agency— is supporting and facilitating this trial. The agency is promoting Colombia's clinical trial capacity to the world, and this trial represents a clear example of how US biotech companies like Libella can cost-effectively gather clinical data from Colombia's 100+ GCP-government-certified world-class clinical research centers.

About bioaccess.™

bioaccess.™ —a Florida-based clinical research company which mission is to help innovative life science companies conduct clinical research and commercialize their innovations in Colombia— will design the study and will provide support services (e.g., regulatory submission, logistical support, project management, statistical analysis, and study monitoring; among others), and will assist Libella register its gene therapy biotechnology product at Colombia's INVIMA for commercialization. More information at www.bioaccessla.com.